Kornimate/medical-research-clean huggingface dataset:
formative research study to address protein intake in children and analysis of breast milk nutrient content in mothers

Conditions: Protein Malnutrition

Summary: this formative research seeks to explore the use of egg (as a potential source of protein) as nutritional supplement for young children aged 6-8 months of either sex and breast milk composition of mothers of infants under 6 months old living in an urban slum of dhaka city, bangladesh.

inadequate dietary protein intake and prolonged undernourishment can lead to short term and long-term consequences, which can deplete financial, physical, and social capital, further exacerbating the cycle of undernutrition. subsequently, undernutrition contributes to the difficulty in achieving sustainable development and alleviating people from poverty. children are a particular focus of interest because of the formative impact that nutrition can have on development. this is particularly relevant for the 159 million children from low and middle-income countries (lmics) who are already stunted and many more are at risk of stunting. understanding how to prevent child undernutrition is imperative to the future development of these children from lmics. there is no study done so far to understand the quantity, preference and quality of egg protein intake in young children living in lmics with high burden of undernutrition. in this context, eggs can serve as a potential source of protein to meet the unmet need of protein especially children living in resource-poor environments. eggs contain high concentrations of choline - an important precursor of phospholipids, which can prevent adverse pregnancy outcomes, neural tube defects, changes in brain structure and function in offspring, and impaired language development during early childhood. evidence is limited on the support of egg-related interventions for better nutrition outcomes in children from developing countries. also there is very little evidence on the association between mother's breast milk composition with child's nutritional status.

Eligibility criteria:
inclusion criteria: (i) consuming complementary food (liquid or semi-solid or solid food) other than breast milk at least once daily; (ii) free from any acute or chronic illness (es); (iii) no known case of congenital abnormality or chromosomal disorder, and (iii) no history of micro-nutrient or food supplementation in last two weeks prior to enrollment (iv) should be breastfed but not exclusively breastfed exclusion criteria: * children whose parents/caregivers refuse to provide informed consent will not be enrolled
the impact of post stenting balloon dilatation on coronary microcirculation in stemi patients undergoing ppci

Conditions: ST-elevation Myocardial Infarction (STEMI)

Summary: this study aims to assess the impact of nc balloon post-dilatation on coronary microcirculation in patients with st segment elevation myocardial infarction (stemi) undergoing primary percutaneous coronary intervention (ppci).

suboptimal stent deployment can lead to future stent failure. thus, optimising stent deployment with non-compliant balloons (nc balloon) post dilatation (pd) at high pressures is an established strategy. in the context of st segment elevation myocardial infarction (stemi), pd has been correlated anecdotally with the no reflow phenomenon. this study aims to determine the impact of stent post-dilation (pd) with nc balloons at high pressures on coronary microcirculation during ppci by measuring the index of microcirculatory resistance (imr) pre and post stent post-dilatation. pre and post pd, an optical coherence tomography (oct) study will be performed to assess stent deployment and identify parameters that predict the changes in imr.

Eligibility criteria:
inclusion criteria * \>18 years of age * acute symptoms onset with duration \> 20 minutes * st-segment elevation ≥ 0.1 mv in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block * infarct related artery with a diameter above 2.5 mm * operator's intention to proceed to stent deployment (i.e. not refer for cabg or defer pci) exclusion criteria * \< 18 year of age * symptoms duration \> 12 hours * unable to give informed consent * previous bypass graft surgery * previous myocardial infarction * pregnancy * known severe chronic kidney disease (creatinine clearance ≤30 ml/min), unless the patient is on dialysis * unable to receive antiplatelets or anticoagulation (i.e. coagulation disorders, bleeding etc.) * haemodynamic instability * severe lms disease * culprit vessel diameter \< 2.5 mm * contraindications to adenosine * any study lesion characteristic resulting in the expected inability to deliver oct catheter to the lesion pre and post pd (e.g. moderate or severe vessel calcification or tortuosity)

Keywords: stemi ppci post-dilatation coronary microcirculation
fontan associated liver disease

Conditions: Fontans

Summary: fontan-associated liver disease (fald), including the development of cardiac cirrhosis and liver neoplasms (benign and malignant), occurs in a majority of patients with congenital heart disease palliated with the fontan operation. however, the specific phenotype (fibrosis only, fibrosis + lesions, etc.) of disease and severity/timing of onset are variable. chronic passive congestion of the liver due to the absence of a functional sub-pulmonary ventricle and resultant chronic central venous hypertension is suspected to be one of the chief drivers of fald and recent work has demonstrated that ultrasound shear wave elastography can be used to noninvasively detect and measure the degree of liver congestion. chronic passive congestion of the liver may also be a predictor of other fontan-related complications, such as protein losing enteropathy, plastic bronchitis, and intractable ascites.


Eligibility criteria:
inclusion criteria: 1. single ventricle physiology congenital heart disease undergoing fontan operation; 2. ≤5 years of age at the time of stage 3 fontan operation; 3. ability to return for follow-up imaging. exclusion criteria: 1. inability to undergo ultrasound imaging. 2. non-english speaking patients, as breath-hold is required for us shear wave elastography in older children due to excursion of the liver with breathing.
development and internal validation of predicting models of idiopathic scoliosis natural history and treatment outcomes through the use of artificial intelligence in a large clinical database

Conditions: Scoliosis Idiopathic

Summary: scoliosis is a three-dimensional deformity of the spine. in its most common form (about 70% of cases), the causes are unknown, therefore it is called idiopathic scoliosis. in most cases, it is discovered after 10 years of age, and is defined diagnostically as a curve of at least 10°, measured on a standing x-ray using the cobb method. if scoliosis exceeds the critical threshold of 30° cobb at the end of growth, there is a progressively greater risk of health and social problems in adult life. for this reason, the main aim of the treatment is to complete the growth period with a curve less than 30° and good sagittal balance, or at least well below 50°, which represents the surgical threshold. growth is a factor favouring the evolution of deformities, therefore patients are followed until the end of growth. this is why therapy can last many years, from the discovery of the presence of a deformity until bone maturation is achieved. the early identification of parameters predictive of the outcome of the therapy to direct the least possible aggressiveness towards the result necessary for the patient's future, integrated with the evaluation of its effectiveness (monitoring), is one of the most important objectives in this field to minimize the burden of treatment in a particular phase of growth such as adolescent development, as well as to identify the subjects most at risk of worsening in adulthood. the systematic collection of clinical data during the therapeutic process offers the possibility, through advanced analysis models, applied retrospectively, to identify predisposing factors and protective factors. when the data available is sufficiently large, it is possible to obtain predictive equations that assist clinicians in therapeutic choices and help patients understand the risks and benefits of available therapies. new technologies such as artificial intelligence techniques offer new and interesting ways of estimating risks and calculating the benefits and safety of some therapeutic choices compared to others. this study aims to develop and internally validate data-driven stratification and prediction models to predict multiple end-of-care outcome measures that include curve magnitude, measured in cobb degrees, measures determining the sagittal balance, and measures of quality of life and function measured through self-completion questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic scoliosis * \< 20 year old exclusion criteria: * secondary scoliosis * history of scoliosis corrective surgery * history of pathologies affecting the spine that can affect the result or spine trauma * iatrogenic scoliosis
prevalence of kidney injury in patients with hcv treated with sofuspovir containing daa therapy

Conditions: Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment

Summary: this study aims is to investigate the occurrence of aki during antiviral therapy, defined as an increase of 0.3 mg/dl or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (egfr) when compared with baseline egfr in egyptian patients.in addition to evaluate the change in insulin resistance value after treating patients from hcv.

there are limited published data, currently, suggesting the risk of aki during oral direct acting antiviral treatment. most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (atn) and acute interstitial nephritis (ain). most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy. recently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' egfr. previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (nsaids) and recurrent ascites were at increased risk for aki during sofosbuvir-based antiviral therapy. the primary endpoint of this study is to investigate the occurrence of aki in egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury.

Eligibility criteria:
inclusion criteria: * patients suffering from hcv * male or female * easy to treat naive patients exclusion criteria: * pregnant women * seffering from hbv * diffecult to treat * other comorbodities as heart diseases or copd

Keywords: daa hcv egyption patients
analysis of imaging features from patients treated with brolucizumab in the post-marketing setting with reports of retinal vasculitis and/or retinal vascular occlusion

Conditions: Intraocular Inflammation; Retinal Vascular Occlusion

Summary: this non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.

the purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (ioi), retinal vasculitis (rv) and/or retinal vascular occlusion (ro) and to provide a description of these features. whenever an ae report pertaining to rv and/or ro was reported to novartis patient safety, a follow-up check list (targeted follow-up checklists \[tfus\]) was sent by novartis to the reporter. the reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). the focus and main efforts of this data collection was on adverse events of rv and/or ro; for other ioi only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter. all images obtained from feb 2020 up to 31 jan 2021 were reviewed in a standardized manner by an external reading center. dedicated grading lists were developed for each of the image modalities: fluorescein angiography (fa), fundus photography (fp), indocyanine green angiography (icga), optical coherence tomography (oct), and oct angiography (oct-a).

Eligibility criteria:
inclusion criteria: * participants with cases of rv and/or ro reported to novartis patient safety following brolucizumab use in routine clinical practice for which images were provided to novartis and read by the reading centre

Keywords: brolucizumab neovascular age-related macular degeneration occlusive retinal vasculitis retinal vasculitis rv retinal vascular occlusion ro ocular images
concomitant use of hepatitis a vaccine with measles, mumps, rubella and varicella vaccine and pneumococcal 7-valent conjugate vaccine in healthy 12-month-old children (v251-067)

Conditions: Hepatitis A Virus

Summary: hepatitis a vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[oka/merck\] virus vaccine at the second dose. immunogenicity and safety data will be collected after each dose of vaccine.

vaccines: v251, hepatitis a vaccine, inactivated (vaqta™) administered with measles, mumps, rubella and varicella vaccine (proquad™) and pneumococcal 7-valent conjugate vaccine (prevnar™) will have a duration of treatment: 2 doses, 6 months apart. vaccine: hepatitis a vaccine, inactivated (vaqta™), administered alone will have a duration of treatment: 2 doses, 6 months apart.

Eligibility criteria:
inclusion criteria: * 12- to 15-month-old males and females with no active liver disease * a negative history of hepatitis a, measles, mumps, rubella, chickenpox, and/or zoster exclusion criteria: * males and females previously vaccinated with hepatitis a, measles, mumps, rubella, and/or chickenpox vaccine * any immune deficiency * history of allergy to any of the vaccine components * history of any seizure disorder

Keywords: hepatitis a virus
pharmacogenomics of stimulant treatment response

Conditions: Attention-Deficit/ Hyperactivity Disorder (ADHD)

Summary: the "pharmacogenomics of stimulant treatment response" (pgx-star) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-24 with attention deficit/hyperactivity disorder (adhd).

background: adhd is a common neurodevelopmental disorder affecting children and adolescents, with psychostimulants, specifically slow-release methylphenidate (e.g., biphentin®, concerta®), being a first-line treatment option. however, the response to medications varies significantly among individuals, with some experiencing limited benefits or intolerable side effects. unlike other areas of psychiatry, adhd pharmacotherapy lacks genetic markers to guide treatment decisions, resulting in delayed symptom relief and diminished quality of life for patients. objectives: 1. identifying genomic profiles associated with psychostimulant treatment response and tolerability in children and adolescents with adhd. 2. establishing a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.

Eligibility criteria:
inclusion criteria: patients will be eligible for participation if all the following are true. * aged 6 - 24 years * located in alberta, canada. * primary diagnosis of adhd (all types). * initiating methylphenidate (excluding immediate release (ir) forms) treatment. exclusion criteria: patients will be excluded from participation if any of the following are true. * co-occurring psychotic, bipolar or eating disorders. * significant risk of suicide. * an intellectual disability, or diagnosis of autism spectrum disorder (asd) or tics/tourette disorders. * past 12-month high-risk alcohol or substance use defined as monthly or more frequent use. * psychotherapy or brain stimulation-based therapy initiated within 8 weeks of referral or plans to initiate/change these types of therapies during the study * history of liver or bone marrow (hematopoietic cell) transplant as these events can result in ambiguous genomic results.

Keywords: children adolescents adhd pharmacogenetics neurology psychostimulants methylphenidate
study on the effects of oxygen-ozone therapy on back pain in subjects aged 65 or older

Conditions: Back Pain

Summary: this study aims to evaluate the efficacy of the oxygen-ozone therapy in the treatment of back pain in subjects aged 65 or older. in particular, the intramuscular injection technique/paravertebral of oxygen-ozone mixture, a minimal invasive treatment with respect to intradiscal infiltration/intraforaminal technique, will be used.

back pain is a leading cause of disability, including impairment in activities of daily living. in particular, the persistence of low back pain is more frequent in the elderly, associated with functional limitations and difficulties to perform tasks in everyday life. in addition to pharmacological treatments, various non-surgical interventional procedures are used for the treatment of low back pain. some recent studies have evaluated the interventional oxygen-ozone (o2-o3) therapy in the treatment of back pain. however, these results are based on the technique of intradiscal infiltration / intraforaminal of o2-o3, while the intramuscular injection technique / paravertebral is the most widely used in clinical practice in italy. in general, minimally invasive treatments such as percutaneous infiltration, are well tolerated and have been shown to produce clinical results, although the number of controlled studies is still scarce and the studies are often not comparable. taking into account the above considerations, it seems appropriate to try to broaden the knowledge on the use of o2-o3 in the treatment of low back pain, using the technique of intramuscular injection / paravertebral, with particular reference to the elderly population. the primary objective of this trial is therefore to evaluate the effects of o2-o3 therapy in the treatment of back pain associated with lumbar disc disease using the technique of intramuscular injection/paravertebral. these effects will be evaluated after a 6 weeks treatment period and after a 3 months follow-up period. the project will include 130 subjects aged 65 or older who will be randomly enrolled in two different types of intervention: * oxygen-ozone therapy * simulated treatment fully described below in the section: interventions in addition to clinical evaluations, the trial will contribute to the study of biological bases of the o2-o3 therapy as the levels of trace elements, oxidative status and antioxidant capacity in plasma will be evaluated.

Eligibility criteria:
inclusion criteria: * patients aged 65 or older * intervertebral disc degeneration * back pain persistent for at least 6 weeks * painkillers and anti-inflammatory drugs * odi score at baseline between 30 and 80% exclusion criteria: * heart failure * favism * clinically hyperthyroidism * cancer and concomitant chemo-or radio-therapy * epilepsy * asthma * life expectancy of 6 months or less * psychotic drugs * clinical signs of radiculopathy * polyradiculopathy * progressive neurological deficit * lumbar stenosis * spondylolisthesis * diabetic neuropathy

Keywords: back pain therapeutics aged injections, intramuscular oxygen ozone geriatric assessment trace elements oxidative stress
ivf outcome after bariatric surgery

Conditions: Infertility; Obesity

Summary: this case-control study compares ivf results and live birth rates in women undergoing ivf with a history of bariatric surgery as compared to 2 age-matched control groups composed of (a) non-operated women matched on cases' post-operative bmi (controls 1) and (b) non-operated severely obese women (controls 2).

a preliminary study in the participating center showed a trend to lower ovarian response to stimulation and live birth rates after bariatric surgery compared to weight-matched patients. however, statistical significance was not reached, as the sample size was small. the aim of the research project is to study the ovarian response and live birth rates of this bariatric surgery population, with a sufficient number of patients, in order to reach higher statistical power. this case-control study will involve 3 ivf (in-vitro fertilization) centers in france . all patients undergoing ivf with a history of bariatric surgery will be included from january 2012. each case will be matched for bmi and age to the 2 next patients without bariatric surgery history and undergoing ivf and to one non-operated severely obese woman. surgery procedures include sleeve gastrectomies and by-passes. the ivf results and live birth rates will be compared between the three groups.

Eligibility criteria:
inclusion criteria: * undergoing ivf and with a history of bariatric surgery

Keywords: assisted reproductive technology obesity bariatric surgery infertility fertility preservation
a study to compare pk, pd and safety of the ad-214-02 and rabeprazole

Conditions: Gastroesophageal Reflux Disease

Summary: a study to compare safety, pharmacokinetics and pharmacodynamics of ad-214-02 to rabeprazole in healthy volunteers.

this study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of ad-214-02 compared with administration of rabeprazole in healthy volunteers.

Eligibility criteria:
inclusion criteria: * age 19\~50 years in healthy volunteers * bmi is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2 * subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * subjects who judged ineligible by the investigator